The recall was initiated because Spice and Spice Inc. has confirmed the whole stemless S4 chilies and Whole with stem S4 chilies are contaminated with pesticide chemical contaminates. The affected products were refused by FDA and they were shipped out to customers by Red Hot Chilies, a third party warehouse.

CGMP Deviations. Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".

Lack of Assurance of Sterility: The product is being recalled due to defective containers. The bags containing the 0.9% Sodium Chloride Injection, USP solution has the potential to leak. Leaking bags have the potential to result in contamination.

CGMP Deviations. Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".

CGMP Deviations. Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".

The printout, display and Operator Manual for the STERIS System 1E Liquid Chemical Sterilant Processing System are subject to recall/correction by the firm because in the event of an incomplete or aborted cycle, the language of the warning messages used in the printout, display, and Operator Manual omits the qualifying term: *liquid chemically* (not **sterilized), when alerting the user to incomplete processing.

The hose clamps in the DxC (with serial numbers less than 3412, labeled behind the lower right side instrument door) hydropneumatic system are sharp and pose a possible risk of injury. An operator could be cut by the hose clamps, which could in turn result in increased exposure to any waste products (biohazards) that might be present on the assembly.

There is a possibility that a specimen could be diluted if a user requests Diluent Dispense while specimens are being automatically processed in cassette presentation. The dilution may cause erroneous results. IMPACT: Erroneous results from a diluted specimen could impact clinical decision making in cases such as blood transfusion, chemotherapy or antibiotic administration- particularly for populations with small volume specimen draws such as newborns.

The recall was initiated because Beckman Coulter identified a problem with occasional unexpectedly high results for RBC, HCT, PLT and MPV without instrument generated messages, for the first run of a capped patient sample. Upon repeat analysis the results are correct. Patients could be affected as described below: (1) False high RBC and HCT may result in a delay of treatment, or the delivery of temporarily ineffective treatment, due to HCT 4.0 - 9.8% misleading effects on diagnoses for anemia, internal bleeding, Polycythemia Vera or dehydration; (2) False high PLT may cause permanent damage to patients with critically low PLT who require immediate corrective or prophylactic platelet transfusion; (3) A false high MPV is unlikely to affect immediate clinical assessment of a patient.

Sharp edges on drawer slides within the DxH800 Floor Stand (Cabinet) may expose operators to physical injury while replacing reagents and waste containers. IMPACT: There is potential for exposure to blood borne pathogens such as HIV, HBV, and HCV.

Maxi Sky 1000/BHM Medical V10 Bariatric Ceiling Lift System; a patient transfer lift; Model numbers LF20010, LF20011, LF20013, LF20014, LF20015, LF21015, LF21019, 9120001, 9120004, 9120005, 9120008, 9120009 and 9121009 The Maxi Sky 1000 is designed for lifting patients in a homecare setting, at nursing homes and other assisted living centers, as well as in institutional or hospital settings. Patient transferring is performed under the supervision of an appropriately trained caregiver staff, in accordance with the instructions for use. All other uses must be avoided. Recall # Z-1983-2011.

The battery-powered control board in the ceiling lift motor may overheat, resulting in smoke and possibly flames and the lift becoming inoperable.

VOLUME OF PRODUCT IN COMMERCE

1,246 units

DISTRIBUTION

Nationwide

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PRODUCT

1) Posterior Referencing Instrumentation for the Nexgen Complete Knee Solution, Femoral and Provisional Impactor/Extractor, REF 00-5901-026-00. This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. Recall # Z-1985-2011;

The firm is initiating a recall due to the potential for breakdown of the AlTiN PVD (black) coating during surgery and the coating could fall into the surgical site. The firm has received 22 reports of the black coating coming off the instruments after cleaning and sterilization cycles and 5 resulted in a delay of surgery.

The software enables programming of the GemStar device for a Bolus Lower Lockout Limit outside of the hard limits entered into the GemStar SP Infusion Suite Database PC application.

VOLUME OF PRODUCT IN COMMERCE

139 units

DISTRIBUTION

Nationwide, Canada, Chile, Colombia and Singapore

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PRODUCT

MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Recall #Z-2059-2011

The Philips MX 16-slice CT scanners are subject to recall/field correction due to a problem encountered with the units when using the 'Combine Viewing' Option. The firm determined that inaccurate dimension measurements display when using the Combine Viewing Option. Moreover, if the dimension measurements from merged images created using this option are used, there is a potential for applying inaccurate dimension information to patients, which could result in misdiagnosis.